Clinical trial · Interventional
Dose Escalation Study for Primary Hepatocellular Carcinoma
Multi-institution Phase I/II Dose Escalation Study of Hypofractionated Stereotactic Body Radiation Therapy for Primary Hepatocellular Carcinoma
NCT00243841CI-TRIAL-00036114SBF-HCCcompletedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine the maximum tolerated dose of limited fractions of large dose radiation in an effort to achieve a biologically potent cancer therapy in selected patients with primary hepatocellular carcinoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Hepatocellular | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Stereotactic Body Radiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Radiation Treatment Arm :A
- description
- Patients with a score of Childs A Will receive 3 fractions of radiation over 5-10 days
- interventionNames
- Radiation: Stereotactic Body Radiation
- type
- EXPERIMENTAL
- label
- Radiation Treatment Arm: B
- description
- Patients with a score of Childs B will receive 5 fractions of radiation over 2-6 weeks.
- interventionNames
- Radiation: Stereotactic Body Radiation
Primary outcomes (2)
- measure
- Number of Patients With DLTs
- timeFrame
- 6 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
Evaluation by the Surgery and/or Liver Transplant Team has been performed and the patient is not considered a candidate for either "standard" therapy to target area (upper abdomen)
* Adequate liver function defined as:
* total bilirubin \< 3mg/dl, albumin \> 2.5 g/dl
* normal PT/PTT unless on anticoagulants
* mild elevation of liver enzymes acceptable (must be less than three times upper limit of normal)
* Adequate renal function (creatinine \< 1.8 mg/dl or creatinine clearance ≥ 50 ml/min)
* Adequate bone marrow reserve:
* ANC count ≥ 1500 mm3
* Platelets ≥ 50,000/mm3
* Hemoglobin \> 9 g/dL
NOTE: Lab values must be obtained within 2 weeks prior to being registered for protocol therapy.
Exclusion Criteria:
* No history of systemic lupus erythematous, rheumatoid arthritis, systemic sclerosis or scleroderma
* No chemotherapy within 14 days before radiotherapy (chemotherapy may cause transient hepatitis with hepatomegaly)
* No subsequent chemotherapy planned within 2 weeks of radiotherapy
* No active liver infection
* No acute Hepatitis. Definition of active disease:
* Hepatitis A: Acute hepatitis determined by presence of Anti-HAV- IgM
* Hepatitis B:
1. HBsAg (HB surface Antigen): present in patients with acute and chronic hepatitis
2. HBV DNA present in patients with active viral replication in amounts greater than 100,000 copies
3. HBeAg is present in wild type HBV infection and suggests active replication
4. Anti-HBs: Antibody against HBsAg appears after HBV infections and confers immunity
5. Anti-HBc-IgM: Antibody against HBcAg, fraction IgM, present in acute infection and often could be detected during periods of high viral replication in chronic disease
6. Anti-HBc-IgG: is present in chronic diseaseReferences
Publications (0)
Data not yet available
No reference posted for this study.